Green Tea and Ultraviolet Light-induced Skin Damage

Phase 2

Terminated

• Conditions: Healthy
• Interventions: Drug: Green Tea; Drug: Placebo

• Registration Number: NCT00134381
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

The purpose of this study is to investigate whether topically applied constituents of green tea \[caffeine or (-)-epigallocatechin gallate; EGCG\] have a protective effect on skin exposed to ultraviolet light (UV).

Detailed Description

The purpose of this study is to investigate if topically applied constituents of green tea \[caffeine or (-) - epigallocatechin gallate; EGCG\] have a protective effect on skin exposed to ultraviolet light (UV). In the double-blinded study all subjects will receive 311 nanometer UVB light at a dose that is 0.5-1.5X their individual minimal erythema dose (MED). One part of the experiment will involve applying a topical natural product (caffeine or EGCG) and placebo to bilateral symmetric sites. The natural product and the placebo will be applied immediately after and at 1/2 hour, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 24 hours, 25 hours, and 27 hours after exposure to a 0.5-1.5 MED dose of UV light. Another part of the study involves performing skin biopsies. One will be done prior to UVB exposure, 2 will be done at 24 hours and 2 more will be done at 48 hours.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-24
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2017-04-11
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-03
• Last Update Submitted: 2017-08-03
• Results First Posted: 2017-09-06
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• The subjects will be normal adult volunteers who are 18 to 65 years of age.

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Exclusion Criteria

• Subjects who drink more than two cups of coffee, tea, or caffeinated soda/beverages per day.
• Subjects who are unable to get an erythemic response (i.e., a sunburn).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active drug	Green Tea	bilateral comparison of green tea constituent
placebo	Placebo	bilateral comparison of placebo vehicle

Primary Outcome Measures

Name	Time	Method
Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds	48 hrs	The mean change in number of active caspase-3+ apoptotic keratinocytes between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells	48 hr	The percentage of phospho-p53 (Ser15) positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.
Change in UVB-Induced Apoptotic "Sunburn" Cells by Green Tea Compounds	48 hr	The mean change in number of apoptotic "sunburn" cells between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic "Sunburn" Cells	48 hr	The percentage of apoptotic "sunburn" cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells	48 hr	The percentage of caspase-3-positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.

Secondary Outcome Measures

Name	Time	Method
Effect of Green Tea Compounds on UVB-Induced Erythema	48 hrs	Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence \[no erythema\]; 1 = mild \[pink or light red color\]; 2 = moderate \[red color\]; 3 = severe \[very red or dark color\]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The mean scores at 48 hr were calculated.
Effect of 4-6% Caffeine on UVB-Induced Erythema	24 hr	Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence \[no erythema\]; 1 = mild \[pink or light red color\]; 2 = moderate \[red color\]; 3 = severe \[very red or dark color\]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The erythema scores at 6, 8, and 24 hr post-UVB were averaged.

Trial Locations

Locations (1)

UMDNJ Division of Clinical Pharmacology; 🇺🇸 New Brunswick, New Jersey, United States